BENITIONSClinical Trial Intelligence

Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

Phase 3 Terminated NCT02859896

ConditionSecondary Hyperparathyroidism-Chronic Kidney Disease
PhasePhase 3
SponsorSanofi
StatusTerminated
Enrollment21 participants
InterventionsDoxercalciferol (GZ427397), Calcitriol
Start dateJan 19, 2017
Completion dateJun 11, 2025
Results postedJul 2, 2026

Summary

Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: * Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.

Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12

Baseline (Day 1) up to Week 12 · percentage of participants

Doxercalciferol (Hectorol®)14.3 percentage of participants
Calcitriol (Rocaltrol®)71.4 percentage of participants
Perecntage difference-52.9 (95% CI -99.90–-5.98)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.